FDA Registration
Active
🇩🇪 Germany
EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG
Reg #: 3003268355
·
FEI: 3003268355
·
Expires 2026
Products
52
Proprietary Names
136
Establishment Types
1
Classifications
52
Registration Details
- Registration Name
- EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG
- Registration Number
- 3003268355
- FEI Number
- 3003268355
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- EUROIMMUN AG, Seekamp 31
- City
- Luebeck Schleswig-Holstein
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K141827
Owner / Operator
- Firm Name
- EUROIMMUN Medizinische Labordiagnostika AG
- Operator Number
- 10025212
- Address
- EUROIMMUN AG, Seekamp 31
- City
- Luebeck
- State
- Schleswig-Holstein
- Postal Code
- D-23560
- Country
- DE
- Correspondent
- Stephan Maihold
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use | PIV | Class 2 | Immunology | No | 2015-05-05 |
| Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | DHN | Class 2 | Immunology | No | 2015-05-05 |
| Elisa, Antibody, West Nile Virus | NOP | Class 2 | Microbiology | No | 2016-09-14 |
| Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | MOB | Class 2 | Immunology | No | 2012-08-30 |
| Antisera, Hai, Influenza Virus A, B, C | GNS | Class 1 | Microbiology | No | 2016-04-07 |
| Legionella, Spp., Elisa | MJH | Class 2 | Microbiology | No | 2016-04-07 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2016-04-07 |
| Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) | MVJ | Class 2 | Immunology | No | 2018-05-28 |
| Reagent, Coronavirus Serological | QKO | Class N | Unknown | No | 2020-03-30 |
| Reagent, Borrelia Serological Reagent | LSR | Class 2 | Microbiology | No | 2016-09-14 |
| Anti-Dna Indirect Immunofluorescent Solid Phase | KTL | Class 2 | Immunology | No | 2018-04-24 |
| Antigen, Fluorescent Antibody Test, Schistosoma Mansoni | GNH | Class 1 | Microbiology | No | 2016-04-07 |
| Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica | JQT | Class 1 | Clinical Chemistry | No | 2016-04-07 |
| Antisera, Positive Control, Echinococcus Spp. | GPE | Class 1 | Microbiology | No | 2016-04-11 |
| Antigen, B. Pertussis | GOX | Class 1 | Microbiology | No | 2016-04-07 |
| Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1) | NBS | Class 2 | Immunology | No | 2012-09-18 |
| Respiratory Syncytial Virus - Elisa | MCE | Class 1 | Microbiology | No | 2016-04-07 |
| Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230 | OEG | Class 2 | Immunology | No | 2012-08-30 |
| Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) | NHX | Class 2 | Immunology | No | 2010-03-10 |
| Antisera, Fluorescent, Brucella Spp. | GSM | Class 2 | Microbiology | No | 2016-04-07 |
| Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3) | NBO | Class 2 | Immunology | No | 2012-08-30 |
| Enzyme Linked Immunoabsorbent Assay, Mumps Virus | LJY | Class 1 | Microbiology | No | 2016-04-07 |
| Antisera, Cf, Adenovirus 1-33 | GOA | Class 1 | Microbiology | No | 2016-04-07 |
| Autoantibodies, Endomysial(Tissue Transglutaminase) | MVM | Class 2 | Immunology | No | 2019-03-06 |
| Station, Pipetting And Diluting, For Clinical Use | JQW | Class 1 | Clinical Chemistry | No | 2016-09-14 |
| Antisera, Cf, Parainfluenza Virus 1-4 | GQT | Class 1 | Microbiology | No | 2016-04-07 |
| Reagents, 2019-Novel Coronavirus Nucleic Acid | QJR | Class N | Unknown | No | 2020-08-04 |
| Microscope, Fluorescence/U.V. | IBK | Class 1 | Pathology | No | 2022-08-24 |
| Anti-Glutamate Receptor (Type Nmda) Ifa | OSK | Class 2 | Immunology | No | 2012-08-30 |
| Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | LJM | Class 2 | Immunology | No | 2013-07-18 |
| Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | LRM | Class 2 | Immunology | No | 2012-08-30 |
| Extractable Antinuclear Antibody, Antigen And Control | LLL | Class 2 | Immunology | No | 2013-04-17 |
| Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. | LJZ | Class 1 | Microbiology | No | 2016-04-07 |
| Autoantibodies, Nuclear Pore Glycoprotein Gp210 | NRI | Class 2 | Immunology | No | 2013-04-17 |
| Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | DBM | Class 2 | Immunology | No | 2013-04-17 |
| Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis | NIY | Class 2 | Immunology | No | 2013-04-17 |
| Autoantibodies, Nuclear Body Protein, Sp100 | NUM | Class 2 | Immunology | No | 2013-04-17 |
| Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6 | GNM | Class 1 | Microbiology | No | 2016-04-07 |
| Antibodies, Gliadin | MST | Class 2 | Immunology | No | 2012-08-30 |
| Anti-Rnp Antibody, Antigen And Control | LKO | Class 2 | Immunology | No | 2013-06-17 |
| Anti-Ribosomal P Antibodies | MQA | Class 2 | Immunology | No | 2013-06-17 |
| Anti-Sm Antibody, Antigen And Control | LKP | Class 2 | Immunology | No | 2013-06-17 |
| System, Test, Vitamin D | MRG | Class 2 | Clinical Chemistry | No | 2013-07-19 |
| Reagents, Cysticercosis | MDJ | Class 1 | Microbiology | No | 2020-07-13 |
| Elisa, Trichinella Spiralis | MDT | Class 1 | Microbiology | No | 2017-11-10 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2017-11-10 |
| Condensers, Microscope | KEI | Class 1 | Pathology | No | 2016-04-07 |
| Anti-Phospholipase A2 Receptor | PGV | Class 2 | Microbiology | No | 2014-06-30 |
| Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System | NVV | Class 1 | Clinical Chemistry | No | 2016-04-07 |
| Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | LJB | Class 1 | Microbiology | No | 2016-04-07 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2022-08-24 |
| Mounting Media | LEB | Class 1 | Pathology | No | 2019-01-09 |
Proprietary Names
IFA 40: HEp-20-10 EUROPattern
EUROPattern Classifier
EUROPattern Microscope
Anti-West Nile Virus ELISA (IgM)
IFA: Granulocytes (EOH)
IFA: Granulocyte Mosaic 2
IFA: Granulocytes (HCHO)
IFA: Granulocyte Mosaic 13
Anti-Influenza A Virus ELISA (IgG)
Anti-Influenza B Virus ELISA (IgG)
Anti-Legionella pneumophila ELISA (IgG)
EUROIMMUN Analyzer I-2P
EUROBlotOne
EUROIMMUN Analyzer I
EUROLabWorkstation ELISA
System liquid concentrate
Sprinter XL
Device Qualification Test Kit EUROLabWorkstation ELISA
IF Sprinter
Device Qualification Test Kit EUROLabWorkstation IFA
Device Qualification Test Kit EUROLabLiquidHandler
Device Qualification Test Kit EUROIMMUN Analyzer I / I-2P
IFA: Granulocyte Mosaic 2 EUROPattern
EUROPLUS Granulocyte Mosaic 22 EUROPattern
EUROPLUS Granulocyte Mosaic 25 EUROPattern
IFA: Granulocyte Mosaic 13 EUROPattern
EUROPLUS Granulocyte Mosaic 32 EUROPattern
Anti-SARS-CoV-2 ELISA (IgG)
Anti-Borrelia burgdorferi US WESTERNBLOT (IgG)
IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern
Anti-Schistosoma mansoni IFA (IgG)
Anti-Schistosoma ELISA (IgG)
EUROLineScan
Anti-PR3-hn-hr ELISA (IgG)
Anti-Echinococcus ELISA (IgG)
EUROLINE-WB Anti-Echinococcus (IgG)
EUROLINE Bordetella pertussis (IgG)
Anti-LKM-1 ELISA (IgG)
Anti-RSV ELISA (IgG)
Anti-BP180-NC16A-4X ELISA (IgG)
Anti-West Nile Virus ELISA (IgG)
IFA: Crithidia luciliae (anti-dsDNA) EUROPattern
Anti-CCP ELISA (IgG)
Anti-Brucella abortus ELISA (IgG)
Anti-Desmoglein 1 ELISA (IgG)
Anti-Desmoglein 3 ELISA (IgG)
Anti-Mumps Virus AT ELISA (IgG)
Anti-Mumps Virus ELISA (IgG)
Anti-Adenovirus ELISA (IgG)
Anti-tissue Transglutaminase ELISA (IgG)
Anti-tissue Transglutaminase ELISA (IgA)
Anti-BP230-CF ELISA (IgG)
EUROBlotMaster 44
EUROBlotMaster
EUROLabWorkstation IFA
UNIQO 160
Anti-Parainfluenza Viruses Pool ELISA (IgG)
EURORealTime SARS-CoV-2
Anti-Glutamate receptor (type NMDA) IFA
ANA Screen ELISA (IgG)
Anti-dsDNA-NcX ELISA (IgG)
Anti-ENA Pool ELISA (IgG)
Anti-Mycoplasma pneumoniae ELISA (IgG)
EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG)
Lyme ELISA (IgG/IgM)
EUROPLUS Granulocyte Mosaic 22
EUROPLUS Granulocyte Mosaic 32
IFA Mosaic: Coxsackie virus B Types (IgG)
IFA Mosaic: Coxsackie virus A Types (IgG)
IFA Mosaic: Coxsackie virus (IgG)
IFA Mosaic: Coxsackie virus Type A7 / Type B1 (IgG)
Anti-Gliadin (GAF-3X) ELISA (IgA)
Anti-nRNP/Sm ELISA (IgG)
Anti-SS-A ELISA (IgG)
Anti-SS-B ELISA (IgG)
Anti-Centromeres ELISA (IgG)
Anti-ribosomal P Proteins ELISA (IgG)
Anti-Scl-70 ELISA (IgG)
Anti-Jo-1 ELISA (IgG)
Anti-Sm ELISA (IgG)
25-OH Vitamin D ELISA
Anti-Toxocara ELISA (IgG)
Anti-Gliadin (GAF-3X) ELISA (IgG)
Anti-Strongyloides ELISA (IgG)
Anti-M2-3E ELISA (IgG)
Coded reagent tray for slides with 50 fields
TITERPLANE set for the incubation of slides with 50 fields
Reagent tray for incubation of slides
Incubation tray 44 channels, black
Coded glass plates for the incubation of slides with 10 fields
TITERPLANE set for the incubation of slides with 10 fields
Coded glass plates for the incubation of slides with 50 fields
Coded reagent tray for slides with 10 fields
EUROStar III Plus
EUROPicture
EUROStar IV Plus
Anti-PLA2R ELISA (IgG)
Anti-PLA2R IFA
EUROLabOffice
EUROLabOffice 4
Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)
EUROLINE ENA ProfilePlus 4 (IgG)
EUROLINE ENA Profile 9 Ag (IgG)
Anti-SLA/LP ELISA (IgG)
ANA IFA: HEp-20-10
IFA 40: HEp-20-10
Anti-Measles Virus ELISA (IgG)
Anti-Measles Virus ELISA 2 (IgG)
ELISA wash buffer 10x conc.
FITC-labelled anti-human IgA with Evans Blue
FITC-labelled Avidin (biotin affine)
FITC-labelled anti-human IgG (primate absorbed)
FITC-labelled anti-human IgG with Evans Blue
Adjustment solution
FITC-labelled anti-human IgA
PBS (IIFT)
EUROArray wash buffer set
Sample buffer 2, Crithidia luciliae sensitive (IFA)
ELISA sample buffer
ELISA Stop solution
Secondary reagents immunoblot (IgM)
ELISA chromogen/substrate solution
Secondary reagents immunoblot (IgG)
Sample buffer (IIFT)
WASH REAGENT 2
EUROSORB (IFA)
Biotin-labelled anti-human IgG
FITC-labelled anti-human IgG
ELISA enzyme conjugate, anti-human IgA
Tween 20 (IFA)
PBS-Tween (IFA)
FITC-labelled anti-human IgG with propidium iodide for EUROPattern
Mounting medium (IIFT)
Anti-MPO ELISA (IgG)
IFA: Oesophagus (Monkey) IgA EUROPattern
IFA: Oesophagus (Monkey) IgA
Establishment Types
Manufacture Medical Device